Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric
FDA device recall Z-1351-2009 · posted 2009-06-01 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Operative Technique: further clarification and guidance is needed to help reduce the potential for distal mis-drilling of the short Gamma3 Trochanteric Nails.
- Action taken
- Stryker sent Urgent Product Recall letters by Federal Express on March 2, 2009 to Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. Letters were sent to all who have used the Gamma3 products in the past.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- JDS
- Quantity affected
- 18232
- Distribution
- Nationwide.
- Date initiated
- 2009-03-02
- Date posted
- 2009-06-01
- Date terminated
- 2012-08-17
- Location
- Mahwah, NJ
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